Item 8.01. Other Events.

On October 21, 2022, Accelerate Diagnostics, Inc. (the "Company") announced it has been in recent discussions with the U.S. Food and Drug Administration ("FDA") regarding its Accelerate Arc system and related BC Kit (collectively, the "Accelerate Arc Products").

Pursuant to such discussions, the FDA has clarified that the Company must obtain a 510(k) clearance in order to continue marketing and distributing the Accelerate Arc Products in the United States. The Company had been listing the Accelerate Arc Products as a Class I device exempt from 510(k) clearance requirements. Additionally, the FDA requested that the Company promptly take certain corrective actions, including, among other things, (i) discontinuing the U.S. marketing and distribution of the Accelerate Arc Products for positive blood culture processing and subsequent identification by mass spectrometry for diagnostic use; (ii) removing and/or correcting all U.S. promotional information within the Company's control (e.g., website, labeling, social media, sales associate information, or other promotional material) regarding the diagnostic use of the Accelerate Arc Products as Class I devices or as devices intended as positive blood culture processing devices for subsequent identification of microorganisms by mass spectrometry; and (iii) revising/removing the Company's registration and listing of the Accelerate Arc Products as Class I devices.

The Company intends to continue to fully cooperate with the FDA, including promptly taking the corrective actions requested by the FDA. On October 21, 2022, the Company also submitted a pre-submission package to the FDA, which is intended to obtain FDA feedback regarding the Company's contemplated submission of an application for 510(k) clearance for the Accelerate Arc Products. The Company cannot, however, give any assurances that FDA will be satisfied with the Company's actions taken in response to the matters raised by the FDA in its discussions. The Company also cannot give any assurances as to the timing of the FDA's response to the Company's pre-submission package or whether the Company will be successful in obtaining 510(k) clearance for the Accelerate Arc Products.

The Company will continue marketing and distributing the Accelerate Arc Products in Europe pursuant to its existing CE In Vitro Diagnostic Regulation (IVDR) registration.





Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect the Company's judgment as of the date of this report. Such forward-looking statements include, but are not limited to, statements relating to the Company's intention to continue to fully cooperate with the FDA, including to promptly take the corrective actions requested by the FDA; expectations and plans regarding 510(k) clearance for the Accelerate Arc Products; and plans to continue marketing and distributing the Accelerate Arc Products in Europe pursuant to its existing CE IVDR registration. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of these results will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties described in the Company's filings with the U.S. Securities and Exchange Commission (the "SEC"), including the Company's Annual Report on Form 10-K for the year ended December 31, 2021 and in the Company's subsequent filings with the SEC. These forward-looking statements are made only as the date hereof, and, except as required by law, the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement.

© Edgar Online, source Glimpses